CTNF 18/463,384 CTNF 99690 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Receipt is acknowledged of IDS filed on 09/08/2023. Claims 1-19 are pending. Claims 13-19 are withdrawn. Election/Restrictions 08-25-01 AIA Applicant’s election without traverse of Group I in the reply filed on 04/13/2026 is acknowledged. Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-36 AIA Claim s 1-12 rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1 and 3 of U.S. Patent No. 12268742 B2 in view of BRADBURY (US 2021/0121569 A1) . The patent teaches a method comprising (a) administering to a tissue of a subject a first composition comprising nanoparticles, wherein the nanoparticles have an average diameter no greater than 20 nm, wherein the nanoparticles comprise: (i) a PDT-active moiety comprising a PDT-photosensitive agent within the nanoparticle, and (b) directing excitation light onto the tissue of the subject to activate the PDT-active moiety; and (c) detecting a signal emitted by the first composition (claim 1), which reads on imaging on a treatment target person into which a first drug particle with a suppressed onset of a treatment effect is introduced, and monitoring an accumulation of the first drug particles in a tissue, and an application step of applying, by an application apparatus, an action for exerting the treatment effect of the first drug particle to the first drug particle accumulating in the tissue, by using as a trigger an event that the accumulation of the first drug particles in the tissue satisfies an objective condition. The patent further teaches wherein the PDT-photosensitive agent comprises methylene blue (claim 3), which is a fluorescent dye . The patent does not teach using CT imaging. BRADBURY teaches a method of injecting a patient with a nanoparticle to a tissue (claim 1 and page 11, paragraph 0110) that comprises a drug (claim 10) and imaging the tissue (claim 23) using computed tomography (page 7, paragraph 0074 and page 15, paragraph 0149). The composition is used for PDT treatment (page 3, paragraph 0026 ). Single-Photon Emission Computed Tomography (SPECT) can be used when the composition comprises fluorescent dyes (page 12, paragraph 0122). The imaging provides both static and functional assessments of the area of treatment (and its surroundings) (page 12, paragraph 0124). It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate CT imaging. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for static and functional assessments of the area of treatment (and its surroundings) , and reasonably would have expected success because the references are in the same field of endeavor, such as nanoparticles injected into the tissue and used for PDT treatment and include a fluorescent dye . Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-07-aia AIA 07-07 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – 07-08-aia AIA (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 5, 10, and 12 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by BRADBURY (US 2021/0121569 A1) . Regarding claim 1, BRADBURY teaches a method of injecting a patient with a nanoparticle to a tissue (claim 1 and page 11, paragraph 0110) that comprises a drug (claim 10) and imaging the tissue (claim 23) using computed tomography (page 7, paragraph 0074 and page 15, paragraph 0149), which reads on a monitoring step of executing, by an X-ray CT apparatus, first CT imaging on a treatment target person into which a first drug particle with a suppressed onset of a treatment effect is introduced, and monitoring an accumulation of the first drug particles in a tissue, based on spectral information acquired by the first CT imaging. Excitation light is then directed onto the tissue to activate the nanoparticle for photodynamic therapy (PDT) (claim 1), which reads on an application step of applying, by an application apparatus, an action for exerting the treatment effect of the first drug particle to the first drug particle accumulating in the tissue, by using as a trigger an event that the accumulation of the first drug particles in the tissue satisfies an objective condition. Regarding claim 5, BRADBURY teaches an energy application divide that supplies power for the excitation of nanoparticle drug complex (page 15, paragraph 0149) which results in the photodynamic therapy that destroys the tumor (page 2, paragraph 0022). Regarding claim 10, BRADBURY teaches the imaging can be used for simultaneous imaging and treatment of diseased tissue. Regarding claim 12, BRADBURY teaches the composition is used to treat cancer (claim 16) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claims 1-1 2 are rej ected under 35 U.S.C. 103 as being unpatentable over LUK IANOVA-HLEB (On-demand intracellular amplification of chemoradiation with cancer-specific plasmonic nanobubbles. Nature America, Inc. 2014) in view of SI-MOHAMED (Spectral Photon-Counting CT Technology in Chest Imaging. Journal of Clinical Medicine. 2021.). Reg arding claim 1, LUKIANOVA-HLEB teaches a liposome particle that is conjugated to a gold nanoparticle (abstract). The liposome encapsulates a drug that is not released right away (abstract), which reads on a suppressed onset of treatment, is injected (page 785, paragraph 2) which reads on which a first drug particle with a suppressed onset of a treatment effect is introduced. An application apparatus exerts a laser pulse that destroys the membrane of the liposome and ejects the drug (abstract), which reads on application step of applying, by an application apparatus, an action for exerting the treatment effect of the first drug particle to the first drug particle accumulating in the tissue, by using as a trigger an event that the accumulation of the first drug particles in the tissue satisfies an objective condition. The composition is meant for imaging as well (figure 2 and page 782, paragraph 3). LUKIANOVA-HLEB does not teach using CT imaging. SI-MOHAMED teaches that CT imaging can be utilized with compositions that have atoms of a high atomic number (abstract), such as gold (page 5, paragraph 2). Imaging allows evaluation of the cancer in a patient’s body and can be used for follow ups after treatment (page 1, paragraph 1). It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate CT imaging. The person of ordinary skill in the art would have been motivated to make those modifications, because it allows for evaluation of the cancer in a patient’s body and can be used for follow ups after treatment, and reasonably would have expected success because the references are in the same field of endeavor, such as compositions comprising gold nanoparticles. Regarding claim 2, LUKIANOVA-HLEB teaches injecting the composition (figure 4), which reads on wherein the application apparatus is a drug injection apparatus. The composition comprises a liposome particle and a gold nanoparticle, which is two particles being injected (abstract), which reads on and the application step includes injecting, by the drug injection apparatus, a second drug particle into the treatment target person. When the gold nanoparticle is exposed to energy it causes an explosion of the liposome which released the drug (figure 1 and abstract), which reads on by using as a trigger an event that the objective condition is satisfied, and exerting the treatment effect of the first drug particle by the action of the second drug particle upon the first drug particle. Regarding claim 3, LUKIANOVA-HLEB teaches that the liposome, which has a membrane, encapsulates a drug (abstract) and when the gold nanoparticle is exposed to energy it causes an explosion of the liposome which released the drug (figure 1 and abstract), which reads on wherein the first drug particle includes a drug for treating the tissue and a membrane that seals the drug, and the application step includes breaking the membrane by the action, which is physical or chemical, between the second drug particle and the first drug particle, and releasing the drug. Regarding claim 4, LUKIANOVA-HLEB teaches a liposome particle that is conjugated to a gold nanoparticle (abstract). The liposome encapsulates a drug that is not released right away (abstract), which reads on wherein the first drug particle includes a first drug with a suppressed treatment effect on the tissue, and a first membrane that seals the first drug. The gold nanoparticle does not inherently cause damage until hit with the energy (abstract), which reads on the second drug particle includes a second drug, which is a drug with a suppressed treatment effect on the tissue and exerts a treatment effect on the tissue by reacting with the first drug. The gold nanoparticle is sealed by a membrane (figure 1), which reads on a second membrane that seals the second drug. Once the composition as a whole is hit with energy, the membrane encapsulating both breaks exerting a treatment effect (figure 1, which reads on the application step includes breaking the second membrane and the first membrane in the tissue, and exerting the treatment effect on the tissue by a reaction between the first drug and the second drug. Regarding claim 5, LUKIANOVA-HLEB teaches that the liposome, which has a membrane, encapsulates a drug (abstract) and when the gold nanoparticle is exposed to energy it causes an explosion of the liposome which released the drug (figure 1 and abstract), which reads on wherein the application apparatus is an energy application apparatus, and the application step includes applying, by the energy application apparatus, energy to the treatment target person, by using as a trigger an event that the objective condition is satisfied, and exerting the treatment effect of the first drug particle by the action of the energy upon the first drug particle. Regarding claim 6, LUKIANOVA-HLEB teaches a liposome that is conjugated to a gold, which has a high atomic number, nanoparticle (abstract), which has a membrane that encapsulates a drug (abstract), which reads on wherein the first drug particle includes a drug for treating the tissue, a high atomic number substance, and a membrane that seals the drug and the high atomic number substance . An application apparatus exerts a laser pulse that destroys the membrane of the liposome and ejects the drug (abstract) by generating heat (page 783, paragraph 4), which reads on the application step includes generating heat by applying the energy to the high atomic number substance, and releasing the drug by breaking the membrane by the heat. Regarding claim 7, LUKIANOVA-HLEB teaches using gold (abstract), which has a high atomic number, and applying energy to it (abstract), which reads on wherein the first drug particle includes a high atomic number substance, and the application step includes applying the energy to the high atomic number substance, thereby generating Auger electrons that exert the treatment effect on the tissue. Regarding claim 8 and 11, SI-MOHAMED teaches that k-edge imaging is utilized with the CT imaging performed with the gold nanoparticles to obtain a clearer image (page 5, paragraph 2) and can allow for a SPCCT image to be obtained (page 13, paragraph 1). Regarding claim 9, LUKIANOVA-HLEB teaches that the liposome, which has a membrane, encapsulates a drug (abstract) and when the gold nanoparticle is exposed to energy it causes an explosion of the liposome which released the drug (figure 1 and abstract), which reads on applying the action to the first drug particles. Note, the MPEP 2106.04(a) recites “The enumerated groupings of abstract ideas are defined as: 1) Mathematical concepts — mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection |); 2) Certain methods of organizing human activity — fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and 3) Mental processes — concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection Ill). In the instant case, the step of a determination step, wherein the determination step includes computing an accumulation index value for quantitatively determining the accumulation of the first drug particles in the tissue, based on the spectral information, and determining whether the accumulation index value satisfies the objective condition is a mental step. Regarding claim 10, SI-MOHAMED teaches that CT imaging can be utilized with compositions that have atoms of a high atomic number (abstract), such as gold (page 5, paragraph 2). Imaging allows evaluation of the cancer in a patient’s body and can be used for follow ups after treatment (page 1, paragraph 1). Regarding claim 12, LUKIANOVA-HLEB teaches that the method is for cancer (abstract). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618 Application/Control Number: 18/463,384 Page 2 Art Unit: 1618 Application/Control Number: 18/463,384 Page 3 Art Unit: 1618 Application/Control Number: 18/463,384 Page 4 Art Unit: 1618 Application/Control Number: 18/463,384 Page 5 Art Unit: 1618 Application/Control Number: 18/463,384 Page 6 Art Unit: 1618 Application/Control Number: 18/463,384 Page 7 Art Unit: 1618 Application/Control Number: 18/463,384 Page 8 Art Unit: 1618 Application/Control Number: 18/463,384 Page 9 Art Unit: 1618 Application/Control Number: 18/463,384 Page 10 Art Unit: 1618 Application/Control Number: 18/463,384 Page 11 Art Unit: 1618 Application/Control Number: 18/463,384 Page 12 Art Unit: 1618
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